Cancer Trials Unit, Princess Alexandra Hospital, Queensland Health, Brisbane, QLD, 4102, Australia.
School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, QLD, Australia.
Patient. 2024 Jul;17(4):335-347. doi: 10.1007/s40271-024-00689-4. Epub 2024 Apr 8.
The history of clinical trials is fraught with unethical practices. Since 1945, robust frameworks have evolved to standardise the collection and reporting of safety data, most notably, the Common Terminology Criteria for Adverse Events (CTCAE) from the National Cancer Institute; used by investigators to report side effects experienced by participants. As medicine moves into the patient-centred model, interest has been growing to collect data on adverse events directly from participants (patient-reported adverse events). The aim of this systematic scoping review was to investigate the inclusion of patient-reported adverse event data within safety/tolerability analyses and explore the collection and reporting of patient-reported adverse event data.
A database search was undertaken and the Covidence platform was used to manage the review; results were analysed descriptively. Sixty-eight studies were included in the analysis. An increase in the number of studies that incorporate patient-reported adverse event data was seen by year. Seventy instruments were used for the collection of patient-reported adverse event data with recall period, mode, frequency and site of administration varying across studies; the duration of data collection ranged from 28 days to 6 years. Frequently, information on these details was omitted from publications. The number of instruments used by studies to collect patient-reported adverse event data ranged from one to seven instruments.
Despite growing calls for the inclusion of patient-reported adverse events, this has not yet translated into published reports. The collection and reporting of these data were variable and conducted using instruments that were not designed for purpose. To address these inconsistencies, standardisation of data collection and reporting using a purpose-built validated instrument is required.
临床试验的历史充满了不道德的行为。自 1945 年以来，已经发展出了强大的框架来规范安全性数据的收集和报告，其中最著名的是美国国立癌症研究所的常见不良事件术语标准（CTCAE）；研究人员用它来报告参与者经历的副作用。随着医学进入以患者为中心的模式，人们越来越感兴趣从参与者（患者报告的不良事件）直接收集不良事件数据。本系统范围综述的目的是调查患者报告的不良事件数据在安全性/耐受性分析中的纳入情况，并探讨患者报告的不良事件数据的收集和报告。
进行了数据库搜索，并使用 Covidence 平台对审查进行管理；结果进行了描述性分析。共有 68 项研究纳入分析。按年份来看，纳入患者报告的不良事件数据的研究数量有所增加。有 70 种工具用于收集患者报告的不良事件数据，研究之间的回忆期、模式、频率和给药部位各不相同；数据收集的持续时间从 28 天到 6 年不等。这些细节的信息经常从出版物中省略。研究中用于收集患者报告的不良事件数据的工具数量从一个到七个不等。
尽管越来越多地呼吁纳入患者报告的不良事件，但这尚未转化为已发表的报告。这些数据的收集和报告存在差异，并且使用的工具不是专门为此设计的。为了解决这些不一致的问题，需要使用专门设计的经过验证的工具来标准化数据的收集和报告。
